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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K230948
Device Name BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
Applicant
Verathon Medical (Canada) ULC
2227 Douglas Road
Burnaby,  CA V5C 5A9
Applicant Contact Chauneen L Wood
Correspondent
Verathon Medical (Canada) ULC
2227 Douglas Road
Burnaby,  CA V5C 5A9
Correspondent Contact Chauneen L Wood
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/04/2023
Decision Date 05/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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